The Coordination of Clinical Research

A novel and indispensable handbook for clinical research coordinators worldwideBecause "e;saying isn't doing; doing is doing"e;: This fourth volume in Mohit Bhandari's series of methodology books, conceived as a transformational guide to executing research for those who coordinate it on a daily basis, focuses not on the design of research projects, but rather on the actual execution of such projects.Key Features:International group of authors and practicing research coordinators with decades of collective hands-on experienceIncludes many crucial, but often neglected, topics such as principles of successful grant writing, working with study budgets, ethics and consent forms, regulatory versus standard trials, coordinating and conducting observational research and randomized clinical trials, and much moreMany helpful templates and sample forms with checklists, consent forms, budget outlines, and moreA broad readership including scientists, physicians, surgeons, epidemiologists and statisticians, and industry research and development directors will welcome this unique and valuable book.

<p><strong>Part I Getting Started</strong><br>1 Leadership and Management: The Principal Investigator and Research Coordinator<br>2 Roles: Why a Research Coordinator is Critical<br>3 Hiring: Characteristics of a Highly Qualified Research Coordinator<br>4 Growth: From 0 to 100, Real Quick!<br><strong>Part II What Every Research Coordinator Needs to Know</strong><br>5 What is Evidence-Based Medicine?<br>6 Randomized Controlled Trials<br>7 Observational Studies<br>8 Surveys<br>9 Qualitative Studies<br>10 Principles of Good Clinical Practice and Research Conduct<br><strong>Part III From Idea to Study Start-Up</strong><br>11 Principles of Grant Writing: Tips for a Successful Experience<br>12 Dollars and "Sense": A Guide to Research Finances<br>13 Maintaining Records and the Trial Master File<br>14 Ethics Submissions<br>15 The Basics of Research Contracts<br>16 How to Start-Up a Study<br><strong>Part IV Study Execution and Close-Out</strong><br>17 Screening and Recruiting Participants<br>18 Obtaining Informed Consent<br>19 Collecting Data: Paper and Electronic Data Capture Systems<br>20 Follow-Up: Why It Is Important and How to Minimize Loss to Follow-Up<br>21 How to Close Out a Study<br>22 Knowledge Dissemination: Getting the Word Out!<br><strong>Part V Advanced Principles of Research Coordination</strong><br>23 Regulatory Trials: Key Differences from Standard Trials<br>24 How to Survive a Site Audit<br>25 Monitoring in a Clinical Study: Why and How?<br>26 Managing Large Studies: Organization and Committees<br>27 International Research: Challenges and Successes<br><strong>Part VI A Coordinator's Toolbox</strong><br>Toolbox A<br>Toolbox B<br>Toolbox C<br>Toolbox D<br>Toolbox E<br>Toolbox F1<br>Toolbox F2<br>Toolbox F3<br>Toolbox F4<br>Toolbox F5<br>Toolbox F6<br>Toolbox F7<br>Toolbox F8<br>Toolbox F9<br>Toolbox F10<br>Toolbox F11<br>Toolbox G</p>